New Regulations to Strengthen Medical Device Patient Safety

New Regulations to Strengthen Medical Device Patient Safety

Quality Systems Now
Published on: 26/10/2025

The introduction of mandatory reporting requirements for medical device-related adverse events marks a significant step forward in enhancing patient safety in Australia.

News
Understanding the Gaps and Overlaps Between ISO 13485, EU MDR, and MDSAP

Understanding the Gaps and Overlaps Between ISO 13485, EU MDR, and MDSAP

Quality Systems Now
Published on: 22/10/2025

ISO 13485, EU MDR, and MDSAP share significant commonalities in quality management, risk control, post-market surveillance, and documentation practices. However, gaps remain in clinical evaluation, UDI compliance, and jurisdiction-specific regulatory requirements.

ISO13485 Certification
General GxP Requirements – GLP, GCP, and GMP

General GxP Requirements – GLP, GCP, and GMP

Quality Systems Now
Published on: 18/10/2025

GLP, GCP, and GMP form the backbone of GxP requirements in the life sciences sector. While each framework has a distinct focus—laboratory studies, clinical trials, and manufacturing—they share core principles.

GMP
Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025

Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025

Quality Systems Now
Published on: 13/10/2025

Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025

Therapeutic Goods Administration News